关于CRA如何快速成长？以及CRA和SCRA的区别？类似这样的问题之前听过很多，如下是最近看到的一篇国外的文章，觉得写得很好，对各位CRA肯定有所帮助，简单翻译一下，供大家参考！
临床研究的职业发展是结构化的。自始至终，你都需要保持上进和激情——乐于学习会让你迅速成长。我们来看看入门级CRA在晋升时提出的一些关键问题。Clinical research offers a structured career progression. Throughout, you will need to remain motivated and passionate – a willingness to learn and travel will enable you to advance swiftly. We look at some of the key questions entry level CRAs ask when it comes to moving up the ranks.
A1：作为CRA1，你需要工作1-3年，才能获得晋升所需的经验和知识。在这几年里，你需要学会以下知识和技能：
As a CRA I, you can expect to work anywhere between 1-3 years before you gain the typical level of experience and knowledge required to progress. During these years, you will need to have acquired the following knowledge and abilities:
如果你觉得这些很熟悉，那么你已经在成为CRA2的道路上了：If these sound familiar to you, you will be on your way to becoming a CRA II:
- 独立检查病例报告表格 Reviewing case report forms (CRFs) without assistance
- 了解关于严重不良事件（SAE）报告的知识，以及如何根据规定继续推进和随访Knowledge of serious adverse events (SAE) reporting and how to proceed and follow up within defined frameworks
- 理解知情同意书（ICF）的内容Understanding the components of informed consent forms (ICFs)
- 中心及试验监查和管理经验Demonstrable site and trial monitoring and management experience
- 启动临床试验中心文件的准备和收集Enabling the preparation and collection of clinical trial site documentation
- 组织和执行中心关闭任务Organising and executing site closeout tasks
A2：如果你渴望快速成长，请充分利用所有的培训和发展机会。很多CRO公司有在线门户网站，你可以通过这些网站获得丰富的知识、参加培训和测验。培训课程可以提供一些必要的技能，帮助你成功晋升到更高的职级，然而，成为CRA并不是一场赛跑。在准备成为CRA2之前，你需要掌握的主要能力，是你每天都会用到的技能和知识。If you are keen to develop quickly, make sure that you take full advantage of all the training and development opportunities available. Many CROs have online portals where you can access a wealth of extra knowledge, training programmes and tests. Training courses are designed to provide the necessary skills to succeed at a more senior level; however, becoming a CRA is not a race. The skills and knowledge you demonstrate on a daily basis are the main competencies you will need to master before considering becoming a CRA II!
Q3我成为SCRA后要做什么？A3：随着你的角色变更，日常工作职责也会增加。你将更多地负责临床试验的准备和关闭。你需要确保所负责的中心效率保持在较高的水平，你可能还要管理一个小型的CRA团队。一对一的指导对多数CRO公司来说很重要，所以你必须准备好帮助那些在你曾经的位置上的人！Your day-to-day responsibilities will increase to reflect your new role. You will become more accountable for preparing and closing clinical trials. You’ll be ensuring that the performance of assigned sites will remain high and you may also be tasked with managing a small team of CRAs. Peer-to-peer mentorship is important to many CROs so you must be prepared to assist people who were once in your shoes!
Q4我怎样才能知道自己是否可以成为SCRA了？A4：作为CRA1，你是否对这个角色的每个方面都很满意？诚实地给自己对于SCRA岗位职责的匹配度做个评价。或许可以问问你的经理你个人的成长情况，以及他/她是否认为你已经充分做好了晋升的准备。根据你与经理共事的时间长短，他们会对你目前的经验水平和是否能成为SCRA有所判断。Are you comfortable with every aspect of your role as a CRA I? Be honest with yourself about how well you fit the advertised SCRA job specification. It may be worth asking your manager about your personal progression and how ready he/she thinks you are. Depending on the length of time you’ve worked with your manager, they will have an understanding about your current level of experience and SCRA suitability.
就像我们之前说的，成为SCRA不是一场赛跑。你的前进路径是独一无二的——有些试验往往更复杂，要求CRA有更多（或更垂直）的经验。对于一个人多久能够成为SCRA，并没有一个特定的参考时间——我们建议你利用所有可利用的培训机会，并在你每天的工作中都认真努力。As we said before, becoming a SCRA is not a race. Your progression curve is unique – some trials are often more complex and require CRAs with more extensive (or niche) experience. There is no set guideline to when someone is ‘ready’ to become a SCRA – we recommend you take advantage of any available training opportunities and continue to work hard in your day-to-day role.
Jesse，某知名外资CRO公司PM
拥有3年药物临床试验项目管理经验
